Celestoderm-V ointment 0.1% 30g №1 (betamethasone)

Name:
Celestoderm-v. Release form Ointment. INN Betamethasone. FTGglucocorticosteroid for local use. Composition 1 g of ointment contains the active substance: betamethasone 1.0 mg (in the form of betamethasone 17-valerate 1.22 mg); excipients: white soft paraffin, mineral oil.
Description:
Soft consistency white homogeneous ointment that does not contain foreign inclusions. Pharmacotherapeutic group Corticosteroids for use in dermatology. Corticosteroids, highly active (group III). ATC code D07AC01. Pharmacological properties Pharmacodynamics Betamethasone valerate is a synthetic glucocorticosteroid for topical use, has a high glucocorticoid activity and a minimal mineralocorticoid effect. Celestoderm-V® ointment has a local anti-inflammatory, antipruritic, anti-exudative and vasoconstrictor effect. Pharmacokinetics Studies on the pharmacokinetics of Celestoderm-B® have not been conducted. After the use of topical corticosteroids, systemic absorption is possible, especially when applied to damaged skin or under occlusive dressings. Indications for use To reduce the inflammatory manifestations of dermatosis sensitive to glucocorticosteroid therapy, such as eczema (atopic, numb), contact dermatitis, seborrheic dermatitis, neurodermatitis, solar dermatitis, exfoliative dermatitis, radiation dermatitis, intertriginous dermatitis, psoriasis (with the exception of widespread psoriasis). Contraindications Untreated skin lesions caused by bacterial infections (for example, pyoderma, tuberculosis and syphilitic processes), as well as viral infections (for example, chickenpox, herpes simplex, herpes zoster, warts vulgaris (warts), molluscum contagiosum); fungal skin infections, widespread psoriasis, parasitic infections, skin ulcers, wounds. The presence of adverse reactions after the use of corticosteroids (for example, perioral dermatitis, stretch marks). Ichthyosis, plantar dermatosis of minors, acne vulgaris, rosacea, increased permeability of the walls of skin blood vessels, skin atrophy, anogenital itching. Celestoderm-B® is contraindicated in patients with hypersensitivity to the active substance or any other component of the drug. Precautions If skin irritation or signs of hypersensitivity occur in connection with the use of Celestoderm-B®, treatment should be stopped and the patient should be given adequate therapy. In the presence of an infection, antifungal or antibacterial agents should be prescribed, respectively. If at the same time the desired effect does not occur quickly, the use of corticosteroids should be stopped until the signs of infection have disappeared. Topical corticosteroids should be used with extreme caution in patients with psoriasis due to the potential for recurrence of the disease, the development of tolerance, the risk of generalization of pustular psoriasis, and the development of local or systemic toxicity due to impaired skin barrier function, as has been reported in several cases. Patients with psoriasis should be closely monitored when topical corticosteroids are used. Prolonged use of strong corticosteroids can lead to the development of atrophic changes, especially on the skin of the face and other sensitive areas of the skin. This circumstance should be taken into account in the treatment of diseases such as psoriasis, severe eczema. As with all potent glucocorticoid-based preparations, the use of Celestoderm-B® should be avoided for long periods of time, on large areas of the skin, and on the face and skin folds. Avoid getting the drug on wounds and mucous membranes. Celestoderm-B® should not be used in ophthalmology or applied to the eyelids due to the risk of developing glaucoma or subcapsular cataracts. Glucocorticoids can change the appearance of some skin lesions, making the diagnosis difficult. Any side effects that occur with systemic use of glucocorticoids, including suppression of the adrenal cortex, may also occur with their topical application. Systemic absorption of topical corticosteroids is increased when they are used for a long time, when treating a large body surface, or when used under occlusive dressings. Due to the content of white soft paraffin, the tear strength and, therefore, the safety of using latex condoms may decrease, this should be taken into account when using the ointment in the genital or anal area. With the use of systemic and local corticosteroids (including intranasal, inhalation and intraocular administration), visual disturbances may occur. If symptoms such as blurred vision or other visual disturbances occur, the patient should be evaluated by an ophthalmologist to evaluate possible causes of visual impairment, which may include cataracts, glaucoma, or rare diseases such as central serous chorioretinopathy, which have been reported after corticosteroid use systemic and local action. Children There are no clinical data on the use of the drug in children, so it is undesirable to use it in patients of this age group. Since in children the ratio of surface area and body weight is greater than in adults, the absorption of the drug is higher. Children are more at risk of developing systemic adverse effects and suppression of the function of the hypothalamic-pituitary-adrenal system when using topical corticosteroids. Use during pregnancy or lactation Animal studies of betamethasone valerate have shown reproductive toxicity. Ointment Celestoderm-B® is not recommended for use in the first trimester of pregnancy. Due to the fact that the safety of the use of topical corticosteroids in pregnant women has not been established, the appointment of these drugs is possible only if the expected benefit to the expectant mother clearly outweighs the potential threat to the fetus. Preparations of this group should not be used in pregnant women in high doses and for a long time. During lactation, the drug should not be used for a long time or on large areas of the skin. During breastfeeding, the ointment should not be used on the skin of the mammary gland, it is necessary to avoid contact of the child with the treated areas of the skin. To date, it has not been clarified whether systemic absorption as a result of topical use of corticosteroids can lead to penetration into breast milk, therefore, when deciding whether to stop breastfeeding or stop using the drug, it is necessary to take into account the importance of the treatment that is carried out for the mother. The ability to influence the reaction rate when driving vehicles or working with other mechanisms As a rule, the drug does not affect the reaction rate when driving vehicles or working with other mechanisms. Dosage and administration Celestoderm-B® is applied in a thin layer to the affected areas of the skin 1-3 times a day, depending on the severity of the condition. In most cases, to achieve the effect, it is enough to apply 1-2 times a day. The frequency of application of the drug is determined according to the degree of damage. With a mild degree of damage, the drug can be applied once a day, in case of more severe lesions, the frequency of application of the drug must be increased. Do not use under occlusive dressings, as side effects of the drug may increase. Continuous use of the drug should not exceed 4 weeks. After achieving a therapeutic effect, you should reduce the frequency of use of the drug Celestoderm-B® or switch to a less active topical corticosteroid and continue maintenance therapy with a gradual withdrawal of the drug. If the condition does not improve or worsens within 2-4 weeks of therapy, it is necessary to re-examine and reconsider treatment. OverdoseSymptoms: Excessive or prolonged use of topical corticosteroids can lead to depression of the pituitary-adrenal function, leading to secondary adrenal insufficiency and symptoms of hypercortisolism, including Cushing’s syndrome. Acute symptoms of hypercortisolism are usually reversible. Treatment: in case of overdose, appropriate symptomatic treatment is indicated. If necessary, carry out a correction of the electrolyte balance. In case of chronic toxic effects, gradual withdrawal of the corticosteroid is recommended. Adverse reactions are presented in accordance with the classification of organ systems and the frequency of occurrence: very often (≥ 1/10), often (≥ 1/100 to < 1/10), infrequently (≥ 1/1000 to < 1/100), rarely (≥ 1/10000 to < 1/1000), very rare (< 1/10000), frequency unknown (cannot be estimated from the available data). From the skin and subcutaneous tissue: Often - burning sensation, itching, irritation, dryness, folliculitis, hypertrichosis, acne-like rashes, hypopigmentation, perioral dermatitis, allergic contact dermatitis. Infrequently - mainly when used under occlusive dressings: skin maceration, skin atrophy, stretch marks, prickly heat. Infections and invasions: Infrequently - a secondary infection (especially when used under occlusive dressings). Particularly sensitive to the development of local adverse reactions are the skin of the face, the surface of the skin with hairline and the skin of the genital organs. After long-term use for the treatment of dermatoses, the withdrawal of potent topical corticosteroids, which include Celestoderm-B®, may aggravate the signs and symptoms of the disease and lead to dependence on topical corticosteroids. All adverse events that have been reported with the appointment of systemic glucocorticoids, including inhibition of the function of the hypothalamic-pituitary system, can develop with the appointment of potent glucocorticoids for topical use. Systemic adverse reactions, such as blurred vision, have also been reported with topical corticosteroids. Interaction with other medicinal products and other types of interactions Interactions are unknown. Shelf life 3 years. Storage conditionsKeep out of the reach of children, at a temperature not exceeding 25°C. Packing 30 g of the drug in aluminum tubes with a membrane, with an internal lacquer coating and a sealed protective ring, a screw cap made of high density polyethylene with a pin for piercing the membrane. 1 tube, along with instructions for use, is placed in a pack of cardboard. Vacation categoryBy prescription. 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